Kornimate/medical-research-clean huggingface dataset:
mobius® post-cesarean pain randomized control trial

Conditions: Complications; Cesarean Section; Pregnancy

Summary: the purpose of this study is to investigate whether the use of the mobius® retractor decreased post-operative pain after cesarean section verses conventional retractor use. based on clinical experience and a pilot study, we suspect that the retractor will decrease overall pain as well as lateral pain.

this is a prospective, randomized, patient blinded trial of standard surgical retraction versus mobius® retraction at cesarean delivery. women will be approached by their provider at their 36 week prenatal visit regarding potential study participation. they will be given a letter describing the study. if a woman is interested, she will be contacted by a study nurse who will obtain informed consent. ideally, women will be approached prior to the onset of labor or date of scheduled cesarean delivery so as to provide adequate time to review the study and ask questions. women who undergo antenatal admission will be also approached by their provider regarding possible study participation and given a recruitment letter. if they are interested, then a study nurse will obtain informed consent. consenting women will be randomized after the decision to deliver by cesarean section is made. randomization will be performed in blocks to control for scheduled versus unscheduled cesarean deliveries using a random numbers generator. assignments will be kept in sequentially number opaque envelopes. women will not be informed of their assignment until after discharge from the hospital. efforts will be made in the operating room to avoid disclosing group assignment and the consent forms will not contain the specific name of the retractor under study. the operative team will be aware of group assignment. participants will complete a 7 item pain scale each post-operative day until discharge. this pain scale has been used in a pilot study and found to be accurate. the pain scale is a single page and takes less than 5 minutes to complete. charts will be reviewed to obtain clinical information which may have an impact on post-operative pain. this includes information about current and past substance abuse. because of the increased amounts of post-operative pain experienced by women who use methadone during pregnancy, this group of women will be excluded from the study. to protect the information regarding substance abuse, a certificate of confidentiality has been obtained from the nih.

Eligibility criteria:
inclusion criteria: * over 18 years old * potential for having a cesarean section (scheduled or unscheduled) at dartmouth hitchcock medical center exclusion criteria: * less than 18 years old * unable to consent due to language barrier or psychiatric illness * current methadone use for chronic pain * stat cesarean section

Keywords: postpartum pain post-cesarean pain surgical retractor elastic retractor
controlled study of ono-8025 (krp-197) in patients with overactive bladder in japan

Conditions: Overactive Bladder

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-8025 (krp-197) in patients with overactive bladder.


Eligibility criteria:
inclusion criteria: 1. patients who are 20 years old or over with overactive bladder 2. total number of urinary incontinence episodes per week is 5 or over 3. mean number of micturition per day is 8 or over 4. mean number of urinary urgency episodes per day is 1 or over 5. other inclusion criteria as specified in the study protocol exclusion criteria: 1. patients with genuine stress incontinence 2. patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection 3. patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study 4. patients suffering from complications for which anticholinergics are contraindicated 5. other exlcusion criteria as specified in the study protocol

Keywords: ono-8025, krp-197, overactive bladder, antimuscarinic
exploring clinical study experiences of people with depression

Conditions: Depression

Summary: the study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. the primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. by joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.


Eligibility criteria:
inclusion criteria: * patient has self-identified as planning to enroll in a clinical trial * patient has been diagnosed with depression * patient is a minimum of 18 years or older exclusion criteria: * patient does not understand, sign, and return consent form * inability to perform regular electronic reporting * patient is pregnant

Keywords: depression
prognosis of heart transplanted patients with heart failure

Conditions: Heart Failure

Summary: heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.


Eligibility criteria:
inclusion criteria: * patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation * individuals whose hearts are donated exclusion criteria: * patients refuse to sign informed consent form

Keywords: heart transplantation heart failure prognosis
coronary artery disease assessment strategies in tavi patients

Conditions: Transcatheter Aortic Valve Replacement; Coronary Artery Disease; Heart Disease Risk Factors

Summary: coronary artery disease (cad) and aortic stenosis frequently coincide. before valve intervention, invasive coronary angiography is routinely performed to assess coronary status. as the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (tavi) is unclear. the cat trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo tavi with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).


Eligibility criteria:
inclusion: • severe aortic stenosis defined by aortic valve area (ava) ≤1cm2 and mean gradient ≥40 mmhg or peak velocity ≥4.0 m/s or if mean gradient \ 2000 agatston units in men, \>1200 in women or if mean gradient \ 2000 agatston units in men, \>1200 in women or if low-dose dobutamine stress echocardiography with flow reserve (\>20% increase in stroke volume) and ava ≤1cm2 * coronary calcium score ≥ 400 agatston units (derived from routine pre-tavi ct) or known coronary artery disease * selected for treatment with transfemoral tavi. * written informed consent. exclusion criteria: * concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention * unprotected left main coronary stenosis \>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-tavi ct * left ventricular ejection fraction (lvef) \< 30% * new regional wall motion abnormalities on echocardiography * myocardial infarction in previous 12 months * coronary angiography in previous 12 months * prior left main stenting
therapeutic strategies during exposure to pain in an experimental design

Conditions: Pain, Acute

Summary: the goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.

exposure therapy is effective for the treatment of individuals with chronic pain and high levels of fear-avoidance. nevertheless, mechanisms of change for exposure treatment are not sufficiently investigated. according to the habituation model, the activation of a fear structure leads to a habituation of the initial physical response. therefore, the therapeutic recommendation is to focus on the reduction of fear during exposure sessions. according to the inhibitory learning approach, however, exposure experiences compete with the original us-cs fear association. therefore, the therapist should maximize the violation of negative expectancies. the present study intends to compare both strategies during the exposure to pain in an experimental design.

Eligibility criteria:
inclusion criteria: * female gender * sufficient knowledge of german language exclusion criteria: * chronic and acute pain conditions * raynaud's disease * high blood pressure * neuropathy, coronary diseases * diabetes, current alcohol * drug or pain-medication (last 24hours)
a descriptive study of baseline characteristics, clinical outcomes, and treatment patterns of hr+/her2- advanced or metastatic breast cancer patients treated with alpelisib plus fulvestrant who have received fulvestrant in any prior line of therapy

Conditions: HR+/HER2- Advanced or Metastatic Breast Cancer

Summary: this was a non-interventional, retrospective cohort study of patients with hr+/her2- abc treated with alpelisib (alp) plus fulvestrant (ful) who have received fulvestrant in any prior line of therapy (lot). this study utilized de-identified individual patient data from the united states (us) concertai patient360 breast cancer database, sourced from electronic health records (ehr) (i.e., secondary use of data). patients were indexed at their start date of the earliest alpelisib plus fulvestrant regimen and followed until their death date or last confirmed activity date in the absence of an observed death.


Eligibility criteria:
inclusion criteria: * had a curated record for advanced or metastatic breast cancer diagnosis. * note: diagnosis of a/mbc is based on a curated record of m stage=m1, stage 4/4a/4b, presence of metastatic tumor, stage 3b/3c or presence of secondary neoplasm. * had patient activity documented in concertai patient 360 breast cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date. * had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date. * had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). this included (neo) adjuvant therapies. * age ≥18 years on the index date. exclusion criteria: * had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or her2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results). * patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date. * patients with "negative" pik3ca test before index date (in case of multiple tests, the one closer to the index date was used).
clinical characteristics of asthma and copd overlap for patients with asthma and copd in hong kong

Conditions: COPD; Asthma

Summary: this study is to assess the prevalence of asthma copd overlap in subjects with diagnosed asthma and chronic obstructive pulmonary disease (copd). the subsequent morbidity and mortality of subjects will be followed up for 3 years.

rationale: around 15 to 20% of copd patients have features of asthma. these patients have more frequent and more severe exacerbations, and higher medical utilization. the global initiative for asthma (gina) and global initiative for chronic obstructive lung disease (gold) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients having asthma-copd overlap (aco). these are at present expert opinions and further studies are needed to establish the optimal definitions and treatment options. the recommendations proposed by the guidelines have been adapted for use in the asia area countries. nonetheless, the application to clinical practice has not been well established and there are no prevalence data available on the copd with asthma symptom population or asthma with copd symptoms population based on the recommended features for identification. this is the current data gap in asia. primary objective: to determine the proportion and clinical characteristics of patients with aco as defined by the joint gina and gold recommendation amongst diagnosed copd and asthma patients seen at the out-patient clinics

Eligibility criteria:
inclusion criteria: subjects must fulfil all of the following criteria: * all patients with confirmed diagnosis of copd (post-bronchodilator fev1/fvc\<0.7 based on the medical records) 1 or asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in fev1 greater than 12% or 400 ml following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 6 * aged \>40 years old * signed written informed consent to participate in the study exclusion criteria: * patients currently with acute exacerbation of copd by gold definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) 1 or acute exacerbation of asthma by gina guideline. 6 * patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (tb)-destroyed lung parenchyma, endobronchial tb, and lung cancer, or those who have history of these diseases based on physician's judgment * patients currently diagnosed with pneumonia and acute bronchitis * patients currently randomized in other clinical studies
safety study of oral mgcd265 administered without interruption to subjects with advanced malignancies

Conditions: Advanced Cancer

Summary: in this study, mgcd265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

mgcd265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. mgcd265 was shown to slow down the growth of human cancer cells in mice. clinical studies are being pursued to evaluate the safety of mgcd265 in cancer patients. in this study, mgcd265 is orally administered on a daily basis to patients with advanced malignancies.

Eligibility criteria:
inclusion criteria: * advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy. * evaluable disease; * last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy; * recovery from the adverse effects ≤ grade 1; * acceptable ecog status 0, 1, or 2; * life expectancy greater than 3 months following study entry; * adequate laboratory values; * for patients enrolling in the four expansion cohorts: * nsclc patients must meet criteria for met and/or axl expression or, * hnscc patients must meet criteria for met and/or axl expression or, * nsclc patients must meet criteria for amplification of the met gene locus, defined met mutations, or rearrangements involving the axl or met gene locus or; * patients with tumor types such as hnscc, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the met gene locus, defined met mutations, or rearrangements involving the axl or met gene locus exclusion criteria: * uncontrolled concurrent illness; * history of cardiovascular illness; * qtc \> 470 msec (including subjects on medication); * left ventricular ejection fraction (lvef) \< 50%; * immunocompromised subjects; * history of bone marrow transplant; * lung tumor lesions with increased likelihood of bleeding; * symptomatic or uncontrolled brain metastases; * unable to swallow oral medications or with pre-existing gastrointestinal disorders.

Keywords: met axl vegfr nsclc hnscc (head and neck squamous cell carcinoma) tumor safety phase 1 solid tumor
clinical study to evaluate the pharmacokinetic characteristics between tmx-67 and feburic® in healthy volunteers

Conditions: Gout

Summary: this study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of tmx-67 (test drug) and feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.


Eligibility criteria:
inclusion criteria: * healthy adult males aged between 20 and 45 years * subjects whose weight is 50 kg or more and bmi is between 18 and 29 kg/m2 * subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions exclusion criteria: * medical history which may influence adsorption, distribution, metabolism, excretion of the drug * clinically significant active chronic disease(s) * persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons

Keywords: crossover pharmacokinetic hyperuricemia gout
administration method of cognitive screening in older individuals with hearing loss

Conditions: Hearing Loss, Sensorineural; Cognitive Impairment

Summary: the objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.

aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. data will be collected from younger individuals with normal hearing. each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. it is anticipated that the scores will not be significantly different between the two conditions. aim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. the three test conditions include auditory unamplified, auditory amplified, and visual. each older individual will be tested using two different test conditions. it is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.

Eligibility criteria:
inclusion criteria: * have sensorineural hearing loss * have normal or corrected-to-normal vision exclusion criteria: * have conductive hearing loss; * have history of otologic or neurologic disorders * have dementia * non-native speakers of english
comparative evaluation of intra-operative peritoneal lavage with super oxidized solution and normal saline in peritonitis cases

Conditions: Peritonitis

Summary: super oxidized solution (sos) was used in peritonitis and results were compared by using normal saline solution in two groups. abdominal fluid was taken to check for bacterial load after giving lavage with sos solution and in other group normal saline. sos is a high level disinfectant, non-flammable and no special training is required to handle it.

aim - to investigate the efficacy of super-oxidized solution (sos) over normal saline in peritonitis. the investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate. methods - a double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at mmimsr, mullana, ambala, india, from december 2014 - november 2015. subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. both the groups underwent peritoneal lavage ; the study group received sos where as control group underwent normal saline lavage. the effectiveness of both the solutions were compared.

Eligibility criteria:
inclusion criteria: * gastric, duodenal, ileal perforation, appendicitis * those patients were willing to participate and the informed consent was taken exclusion criteria: * evidence of enteric encephalopathy * liver diseases * renal diseases * heart disease * known allergy to any substance * multiple trauma or organ injury * any gynaecological etiology

Keywords: peritonitis solutions normal saline infection peritoneal lavage
the effect of modular education on individuals diagnosed with hypertension

Conditions: Hypertension

Summary: aim:this study focused on patients with hypertension to investigate the effect of a nurse-led counseling program on their self-efficacy and disease adherence.

this study adopted a randomized-controlled and intervention research method. data were collected between september 2022 and february 2023 at the internal medicine outpatient clinic of adana city hospital. participants were recruited using random sampling. simple randomization was used to allocate both groups equally and randomly (https://www.randomizer.org/). the researcher first created a randomization list. then, she assigned participants to the intervention and control groups according to the list. blinding was impossible because the research involved a training program. a power analysis (g\*power 3.1.9.4) was performed based on the effect size (d = 0.93) reported by zhang et al. (zhang et al., 2021). the results showed that a sample of 62 would be large enough to detect significant between-group differences (power 95%, margin of error 5%, and confidence interval 95%). the results showed that a sample of 42 was large enough to detect significant differences \[alpha= 0.05 and power (1- beta) 0.80\]. however, each group comprised 23 participants to avoid missing data and the execute parametric tests.data were collected using a personal information form, the hypertension self-efficacy scale (hses), the modified morisky scale (mms), and the adaptation to chronic illness scale (acis). the inclusion criteria were (1) having had hypertension at least for six months, (2) being an adult (over 18), (3) not having received training on hypertension before, (4) having no communication problems, (5) not being pregnant, and (6) volunteering.

Eligibility criteria:
inclusion criteria: * having had hypertension at least for six months * being an adult (over 18), * not having received training on hypertension before, * having no communication problems, * not being pregnant, * volunteering exclusion criteria: * hypertension diagnosis duration is less than 6 months * having verbal communication problems * not volunteering to participate in the study

Keywords: hypertension nursing self-efficacy modular training adaptation to chronic illness